Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

• Histological confirmation of triple-negative breast cancer on primary tumour at diagnosis/on biopsy of metastasis.

• At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

• Fail first-line or above anti-tumor treatment.

• Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.

• Compliance with the study protocol.

• Have provided written and signed informed consent.

• Minimum life expectancy 16 weeks.

Exclusion Criteria:

• Pregnant or breast feeding.

• Uncontrolled medical problems.

• Evidence of active acute or chronic infection.

• Hepatic, renal, cardiac, or bone marrow dysfunction.

• Concurrent malignancy or history of other malignancy within the last five years.

• Known severe hypersensitivity to Chidamide or Zimberelimab

• Patients were unable or unwilling to comply with program requirements.